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Nocturnal EnuresisNCT04620356

Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)

A study testing DryNites Pyjama Pants in people with Nocturnal Enuresis, run by Kimberly-Clark Corporation at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Children vary in the age at which they achieve night-time dryness; in almost all cases children will stop bed-wetting without any need for treatment. Use of absorbent pants for the management of nocturnal enuresis is controversial regarding the impact on the speed at which children become dry throughout the night. Read more about this study

Who is it for?
Ages 4 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Nocturnal Enuresis
What is being tested?
DryNites Pyjama Pants
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
2 sitesUnited Kingdom
Study dates
21 Feb 2020to 28 Jun 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Patient aged between 4-8 years at the time of enrollment
  • Have a clinical diagnosis of monosymptomatic primary NE
  • Have been dry in the day for >/= 6 months prior to enrollment
  • Have on average no more than 1 dry night per month during the past 6 months at enrollment
  • Have an informed consent signed by the their parent(s)/carer(s)

Who cannot join

  • Children in foster/court care
  • Have implemented any previous intervention to address NE (use of prescribed alarm schedule, desmopressin, imipramine, anticholinergics) or withdrawal of pants/nappies for > 7 days in the previous 6 months
  • Have secondary NE
  • Have wetting in the day
  • Have faecal soiling
  • Have known urinary tract disease
Show all 10Show fewer
  • Have diabetes
  • Receive any regular intake of medication
  • Have a known developmental/neurological disorder
  • Have links to Kimberly-Clark of any kind (including family relations employed by Kimberly-Clark, holding stocks or share in Kimberly-Clark)

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites
  • Mounts Bay Medical

    Connor, Haley, TR27 5DT

  • Siddarth Marnekar

    Hull, HU12 8JD

Other trials in United Kingdom

About this study

Children vary in the age at which they achieve night-time dryness; in almost all cases children will stop bed-wetting without any need for treatment. Use of absorbent pants for the management of nocturnal enuresis is controversial regarding the impact on the speed at which children become dry throughout the night. The aim of this study is to determine the effect of using DryNites absorbent pants in children with monosymptomatic nocturnal enuresis on the speed they become dry throughout the night compared with removing absorbent pants.

Read the detailed description

Children with severe monosymptomatic NE between 4 and 8 years of age were recruited from study centers in Denmark, Belgium, and the UK. All participants had used absorbents pandt of any manufacturer for at least the previous 6 months. Participants fulfilling the inclusion criteria entered a 4-week run-in period during which they slept wearing the intervention absorbent pant. To be eligible for randomization, participants needed to have 7/7 wet nights in the last week of the run-in period. Eligible participants were then randomly assigned (2:1) to either discontinuation or continuation of absorbent pants for the 4-week core intervention period. The children sleeping without absorbent pants were permitted to sleep with an absorbent bed mat instead. No behavioral changes such as fluid restriction or lifting the child to the toilet when the parents went to bed were allowed in either group. After completing the core intervention period, participants were invited to take part in a 4-week extension period, during which they would remain on their randomly assigned treatment. Number of wet nights were assesed during the study using an electronic diary. Quality- of- life (QoL) and sleep parameters were assessed using the following validated questionnaires: Paediatric Incontinence Questionnaire (PinQ), World Health Organization Quality of Life Brief Version Paediatric Daytime Sleepiness Scale (PDSS), and Checklist Individual Strength. Questionnaires were completed jointly by children and parents.

Being tested
DryNites Pyjama Pants
Medical subject headings
Nocturnal Enuresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DryNites Pyjama PantsDevice

    DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.

Study groups in NCT04620356
Study groupRoleWhat they receive
DryNites armExperimentalParticipants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night.
Receives: Device: DryNites Pyjama Pants
No Pants armNo interventionParticipants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wet Nights

    Average number of wet nights

    Measured: Last week of the 4-week intervention period

Secondary outcomes (4)
  1. Impact of Urinary Incontinence on Emotional Wellbeing of Child as Assessed by Paediatric Incontinence Questionnaire (PinQ)

    The PinQ will be used to assess the child's QoL. The PinQ is a validated cross-cultural continence-specific paediatric QoL questionnaire to assess children with bladder dysfunction, developed by Bower el al (Bower et al. 2006). It is available as self-rated and proxy versions.

    This will be completed by the child themselves in the older participant group and will be completed by the parent/carer on behalf of the child in the younger participant group.

    The PinQ measures the emotional impact that urinary incontinence has on a child. It consists of 20 urinary incontinence QoL related questions divided in 2 dimensions: intrinsic (14 items) and extrinsic (6 items), which are graded on a scale of 0 to 4 (0=No, 1=Hardly ever,2=Sometimes, 3=Often, 4=All the time) with a score range of 0 to 80.

    The total score indicates the impact urinary incontinence has on the child's QoL with the higher scores indicating a more significant effect.

    Measured: Assessment will be done at each study clinic visit (Day 56 +/- 7)

  2. Impact of Child Nighttime Enuresis on Parent/Carer Quality of Life as Assessed by the WHOQoL-BREF Questionnaire

    The WHOQoL-BREF questionnaire (WHO 1996) will be completed directly by the parent/carer. . The WHOQoL-BREF questionnaire is derived from a larger instrument, the WHOQoL-100. It includes 26 items, grouped in 4 domains: Physical Heath, Psychological, Social Relationships, and Environment, and 2 separate items asking the crespondent about overall perception of QoL (item 1) and an individual's overall perception of their health (item 2). The scores of items 3, 4 and 5, which are negatively phrased, need to be reversed. The mean score of items within each domain is used to calculate the domain scores, which are converted into a 0-100 scale. Higher scores denote higher QoL. Where more than 20% of data is missing from an assessment, the assessment should be discarded. Where an item is missing, the mean of other items in the domain is substituted. Where more than 2 items are missing from the domain, the domain score should not be calculated

    Measured: Assessment will be done at each study clinic visit (Day 56 +/- 7)

  3. Child Daytime Sleepiness as Assessed by PDSS Questionnaire

    The Paeditric Daytime Sleepiness Scale (PDSS) questionnaire measures daytime sleepiness in children. It is comprised of 8 items assessing daytime sleepiness and rated on a 5-point scale with 0 = Never and 4 = Always/Very Often. The scale ranges from 0 to 32. The questionnaire will be completed by the child themselves (with attendance of an adult) in the older participant group and by the parent/carer on behalf of the child in the younger participant group. Higher scores indicate greater daytime sleepiness. Higher scores indicate greater daytime sleepiness, and were associated with reduced total sleep time, poorer school achievement, poorer anger control, and frequent illness.

    Measured: Assessment will be done at each study clinic visit (Day 56 +/- 7)

  4. Parent/Carer Fatigue as Assessed by Checklist Individual Strength (CIS Questionnaire)

    The CIS questionnaire was used to assess the parents' sleep. It was completed directly by the parent/carer. The CIS consists of 20 statements on fatigue-related problems responders might have experienced in the past 2 weeks. A Likert scoring scheme from 1 to 7 ranging from 1-"no, that is not true" to 7-"yes, that is true" with items 2, 5, 6, 7, 8, 11, 12, 15 and 20 hold inverted scores. The total score ranges from 20 to 140. The questionnaire covers measures 4 dimensions of fatigue: Subjective fatigue severity (8 items), Concentration problems (5 items), Reduced motivation (4 items) and Physical activity (3 items). Dimensions can be analyzed separately, with higher scores indicating higher levels of subjective fatigue (8-56), reduced concentration (5-35), reduced motivation (4-28), and lower levels of physical activity (3-21). A total score over 76 is considered at risk of a fatigue disorder, while 36 provides the cutoff score on the subjective experience of fatigue sub-scale

    Measured: Assessment will be done at each study clinic visit (Day 56 +/- 7 )

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2020
  2. Study start21 Feb 2020
  3. Primary completion28 Jan 2023
  4. Study completion28 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04620356
Sponsor's protocol ID
KCC-DN-001
Status last verified
Oct 2024
First submitted
23 Sep 2020
Last updated
6 Dec 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Breinbjerg A, Kamperis K, Thorsteinsson K, Jorgensen CS, Dossche L, Rayner J, Zhang J, Rodrigues DG, Borch L, Hagstrom S, Tekgul S, Walle JV, Rittig S. Discontinuing absorbent pants in children with bedwetting: a randomized controlled trial. Eur J Pediatr. 2024 May;183(5):2443-2453. doi: 10.1007/s00431-024-05502-w. Epub 2024 Mar 12.

    PubMed 38472381

Questions about this trial

What is this clinical trial studying?

A study testing DryNites Pyjama Pants in people with Nocturnal Enuresis, run by Kimberly-Clark Corporation at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wet Nights (time frame: Last week of the 4-week intervention period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04620356, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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